BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1571611 · Received December 11, 2009

    Report

    Report Number
    1219856-2009-00560
    Event Type
    Malfunction
    Date Received
    December 11, 2009
    Date of Event
    November 30, 2009
    Report Date
    December 11, 2009
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE MD INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH INTO THE FEMORAL ARTERY. THE MD BEGAN TO INSERT THE IAB INTO THE SAF SHEATH AND THE IAB BECAME STUCK. AS A RESULT, THE IAB AND THE SAF SHEATH WERE REMOVED AS ONE UNIT. THE MD REQUESTED ANOTHER IAB-05840-LWS AND THIS TIME THE IAB WAS INSERTED THROUGH THE SAF SHEATH WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK